The journey of completely indigenous coronavirus vaccine (Covaxin) in less than 8 months showcases the immense strength of Atmanirbhar Bharat (self-reliant India) to fight the odds and stand tall in the global public health community, said ICMR Director General Dr Balram Bhargava while commenting on the efficacy results of Bharat Biotech's vaccine candidate Covaxin.
The Hyderabad-based drug maker, Bharat Biotech, said on Wednesday that Covaxin had demostrated an interim efficacy of 81 per cent in preventing Covid-19 in late-stage clinical trials.
"This is also a testament to India’s emergence as a global vaccine superpower," the ICMR chief said.
The trials, which are the largest ever conducted in India, involved 25,800 participants across 21 sites. The vaccine was developed in partnership with Indian Council of Medical Research (ICMR), the Indian government's medical research body.
The interim efficacy trend of 81 per cent, analysed as per the protocol approved by the drug regulator DCGI, puts it at par with other global front-runner vaccines, the government said.
The Covaxin is the first Covid-19 vaccine that has been developed completely in India. In March 2020, following the successful isolation of the SARS CoV-2 virus at ICMR-National Institute of Virology (NIV), ICMR entered into a public-private partnership with Bharat Biotech to develop the virus isolate into an effective vaccine candidate. ICMR-NIV characterized the vaccine developed by BBIL through in-vitro experiments and electron microscopy studies.
Pre-clinical studies in small animals and hamsters showed promising results in terms of safety and immunogenicity. Further studies conducted in rhesus macaques also established remarkable safety and protective efficacy of Covaxin. Phase 1 and Phase 2 clinical trials conducted in 755 participants demonstrated high safety profile of the candidate vaccine with sero-conversion rates of 98.3 per cent and 81.1 per cent on day 56 and 104respectively.
Covaxin has been developed on the WHO prequalified verocell platform, which is globally recognized with a well-established track record of safety. The vaccine's ability to neutralize UK variant strain of SARS-CoV-2 has also recently been established.
“The development and deployment of Covaxin ensures that India has a powerful weapon in its arsenal in a continually evolving pandemic situation and will go a long way in helping us win the war against COVID-19. The need of the hour is to ensure that people in India continue to receive the vaccine and break the chain of virus transmission,” said Dr. Samiran Panda, Head, Epidemiology and Communicable Disease, ICMR and Director, National AIDS Research Institute.